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Pragmatic trials are studies designed to provide information for the practice of clinical trials in real life. They are typically characterized by a focus on the practical aspects of the study design, such as the recruitment and consent process in adherence, as well as the use of standard equipment.
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A pragmatic trial that uses various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for a pragmatic trial to be reliable and reduce bias in results is also essential. However excessive heterogeneity could result in problems with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are typically commissioned by practitioners and policy makers to aid in their decision-making. They can also be a great method of determining the cause-effect relationship between an intervention and its results. They should, however, not, be used to replace explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis and pragmatic trials, which inform policy and practice decisions. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, and the follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming more acquaint to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.